Clinical Trials /

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

NCT03033511

Description:

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03033511

Trial Eligibility

Document

Title

  • Brief Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

Clinical Trial IDs

  • ORG STUDY ID: M16-298
  • SECONDARY ID: 2016-003503-64
  • NCT ID: NCT03033511

Conditions

  • Small Cell Lung Cancer (SCLC)

Interventions

DrugSynonymsArms
Rovalpituzumab tesirineRovalpituzumab tesirine/dexamthasone
DexamethasoneRovalpituzumab tesirine/dexamthasone
Placebo for rovalpituzumab tesirinePlacebo
Placebo for dexamethasonePlacebo

Purpose

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab tesirine/dexamthasoneExperimentalRovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omit every 3 cycles
  • Rovalpituzumab tesirine
  • Dexamethasone
PlaceboExperimentalPlacebo q6 wk; omit every 3 cycles
  • Placebo for rovalpituzumab tesirine
  • Placebo for dexamethasone

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed extensive-stage disease small cell lung
             cancer (ED SCLC) with ongoing clinical benefit (stable disease [SD], partial response
             [PR], or complete response [CR]) following completion of 4 cycles of first-line
             platinum-based therapy

          -  At least 3 but no more than 9 weeks between the administration of the last cycle of
             platinum-based chemotherapy and randomization.

          -  Participants with a history of central nervous system (CNS) metastases prior to the
             initiation of first-line platinum-based chemotherapy must have received definitive
             local treatment and have documentation of stable or improved CNS disease status

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

          -  Participants must have adequate bone marrow, renal and hepatic function

          -  Availability of archived or representative tumor material for assessment of DLL3
             expression

        Exclusion Criteria:

          -  Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint
             inhibitors, other monoclonal antibodies, antibody-drug conjugates,
             radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other
             anti-cancer therapy than that described in inclusion criteria

          -  Any disease-directed radiotherapy (except prophylactic cranial irradiation or
             pre-planned radiotherapy for CNS metastases present prior to start of first-line
             therapy and non-progressing) after last dose of first-line chemotherapy.

          -  Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based
             drug, prior participation in a rovalpituzumab tesirine clinical trial, or known
             hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient
             contained in the drug formulation.
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC)
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first.

Secondary Outcome Measures

Measure:Objective response rate (ORR) per the CRAC based on RECIST v1.1
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:ORR the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.
Measure:Change in patient reported outcomes (PROs)--physical functioning domain
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30
Measure:Progression-free survival (PFS) per investigator assessment based on RECIST v1.1
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:PFS is defined as the number of months from randomization to disease progression, as assessed by the investigator per RECIST version 1.1, or death of any cause, whichever occurs first.
Measure:ORR per investigator assessment based on RECIST v1.1
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:ORR is the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.
Measure:Clinical benefit rate (CBR) per the CRAC assessment based on RECIST v1.1
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.
Measure:CBR per the investigator assessment based on RECIST v1.1
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per investigator from the date of randomization until disease progression or death, whichever occurs first.
Measure:Duration of response (DOR) per the CRAC assessment
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:DOR is the time from the initial objective response (CR/PR) by CRAC to disease progression or death, whichever occurs first.
Measure:DOR per the investigator assessment
Time Frame:Approximately 31 months since first subject enrolled
Safety Issue:
Description:DOR is the time from the initial objective response (CR/PR) by investigator to disease progression by investigator or death, whichever occurs first.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Extensive-Stage Small Cell Lung Cancer (ED SCLC)
  • Rovalpituzumab tesirine
  • first-line chemotherapy
  • Cancer
  • Platinum-Based Chemotherapy

Last Updated

March 30, 2017